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Trial Title:
Data Analysis for Drug Repurposing for Effective Alzheimer's Medicines (DREAM)- Anastrozole vs Exemestane/Letrozole
NCT ID:
NCT05635357
Condition:
Breast Cancer
Conditions: Official terms:
Letrozole
Anastrozole
Exemestane
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Drug
Intervention name:
Anastrozole
Description:
Anastrozole claim is used as the exposure group.
Arm group label:
Anastrozole
Intervention type:
Drug
Intervention name:
Exemestane/Letrozole
Description:
Exemestane/Letrozole claim is used as the reference group.
Arm group label:
Exemestane/Letrozole
Summary:
This study aims to evaluate the comparative risk of dementia/Alzheimer's disease onset
between patients treated with medications that target specific metabolic pathways and
patients treated with alternative medications for the same indication.
Detailed description:
This is a non-randomized, non-interventional study that is part of the DREAM Study of
Brigham and Women's Hospital. DREAM is led by Dr. Madhav Thambisetty, MD, PhD, Chief of
the Clinical and Translational Neuroscience Section, Laboratory of Behavioral
Neuroscience, National Institute on Aging (NIA) intramural research program. This study
aims to evaluate the comparative risk of dementia/Alzheimer's disease onset between
patients treated with medications that target specific metabolic pathways and patients
treated with alternative medications for the same indication using healthcare claims
data.
Criteria for eligibility:
Study pop:
This study will employ a new user, active comparator, observational cohort study design
comparing Anastrozole vs Exemestane/Letrozole. The patients will be required to have
continuous enrollment during the baseline period of 365 days before initiation of study
drugs (cohort entry/index date). Follow-up for the outcome (dementia) differs between
analyses. Follow-up begins the day after drug initiation (analysis 1, 3, 4); 180 days
after drug initiation (analysis 2).
Sampling method:
Non-Probability Sample
Criteria:
Please see
https://docs.google.com/spreadsheets/d/1GrnVsPCockqqdfxC9LWd6ndbzS2wpJVvTbCOAhn4DLM/edit?
usp=sharing or Appendix A
(https://drive.google.com/drive/folders/1I8FVmpPzC5wQN9DFIv1Rbwh1N0SLEv0B?usp=sharing)
for full code and algorithm definitions.
Medicare timeframe: 2008 to 2018 (end of data availability)
Inclusion Criteria:
-
1. Aged >/= 65 years on the index date
-
2. Enrollment in Medicare Part A, B, and D with no HMO coverage for 365 days prior
to and including cohort entry date
-
3. At least two claims with breast cancer diagnosis measured 365 days prior to
drug initiation
Exclusion Criteria:
-
1. Prior history of dementia measured anytime prior to cohort entry date
-
2. Prior history of nursing home admission anytime prior to cohort entry date
-
3. Prior history of Anastrozole or Exemestane/Letrozole use anytime prior to
cohort entry date
Gender:
All
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02120
Country:
United States
Start date:
November 1, 2022
Completion date:
December 31, 2023
Lead sponsor:
Agency:
Brigham and Women's Hospital
Agency class:
Other
Collaborator:
Agency:
National Institute on Aging (NIA)
Agency class:
NIH
Collaborator:
Agency:
Rutgers University
Agency class:
Other
Collaborator:
Agency:
Johns Hopkins University
Agency class:
Other
Source:
Brigham and Women's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635357
